Status:
RECRUITING
Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
Lead Sponsor:
Mode Sensors AS
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Overhydration
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigation is a prospective cohort study, where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment. The overall objective is to assess the b...
Detailed Description
In Sub-investigation A, patients will be monitored for at least 10 consecutive dialysis sessions, and for a minimum of 3 weeks. Patients will wear two sensors (upper back and lower anterior leg). In ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A)
- Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B)
Exclusion
- Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
- Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
- Patients undergoing MRI
- Breached skin at patch mounting area
- Pregnancy
- Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06053710
Start Date
November 13 2023
End Date
December 31 2024
Last Update
February 20 2024
Active Locations (2)
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1
Rikshospitalet, Oslo University Hospital
Oslo, Norway
2
Ullevål sykehus, Oslo University Hospital
Oslo, Norway